Clinical Applications of FAPI PET in Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRuijin Hospital
About this trial
The study systematically evaluates the diagnostic performance of FAPI-RuiJ and FAPI-04 PET/CT or PET/MR in various solid tumor types, and is expected to provide a novel molecular imaging tool for early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years and ≤ 80 years, regardless of gender.
Participants with suspected, confirmed, or suspected recurrent solid tumors.
Participants who agree to participate in this clinical trial and provide written informed consent.
Participants with good compliance, who commit to adhering to the study procedures and cooperate with the full study process.
Disqualifiers
Patients with severe medical conditions that, in the investigator's opinion, make them unsuitable for participation in this clinical study, including but not limited to: severe cardiopulmonary insufficiency, severe bone marrow suppression, and severe hepatic or renal insufficiency.
Patients with claustrophobia, severe psychiatric symptoms, or impaired consciousness that precludes cooperation with the examination procedures.
Patients who have received any anti-tumor therapy during the interval between the two PET imaging sessions.
Pregnant or breastfeeding women.
Trial design
Design model
Crossover
Treatments tested in this trial
FAPI-RuiJ
Diagnostic testA novel FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.
FAPI-04
Diagnostic testA FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Participants will undergo FAPI-RuiJ PET/CT or PET/MR, followed by FAPI-04 imaging on a separate dayExperimental treatment 2 interventions
Group B: Participants will undergo FAPI-04 PET/CT or PET/MR, followed by FAPI-RuiJ imaging on a separate dayExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Diagnostic sensitivity, specificity, PPV, NPV, and accuracy of FAPI-RuiJ PET versus FAPI-04 PET
Overall and tumor type-specific diagnostic performance in solid tumors, using histopathology or imaging follow-up as the reference standard.
Time frame
Through study completion, an average of 3 years2
AUC of FAPI-RuiJ PET versus FAPI-04 PET
Overall and tumor type-specific AUC comparison between the two tracers in solid tumors, using histopathology or imaging follow-up as the reference standard.
Time frame
Through study completion, an average of 3 yearsSecondary outcomes
1
Comparison of SUVmax, SUVmean, and SUVpeak of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions
Semi-quantitative comparison of standardized uptake value (SUV) parameters (SUVmax, SUVmean, and SUVpeak) between the two tracers in solid tumor lesions.
Time frame
At the time of PET/CT scan2
Comparison of TBR of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions
Semi-quantitative comparison of TBR between the two tracers in solid tumor lesions. TBR is calculated as the ratio of tumor SUVmax to background SUVmean.
Time frame
At the time of PET/CT scan3
Biodistribution characteristics of FAPI-RuiJ PET in normal organs
Quantitative assessment of FAPI-RuiJ tracer biodistribution in major normal organs (including brain, submandibular gland, thyroid, lung, descending aorta, heart, liver, pancreas, stomach, spleen, kidney, bone, muscle, small intestine, gallbladder) measured by SUVmean and SUVmax on PET/CT images using ROI-based analysis.
Time frame
At the time of PET/CT scan4
Correlation between FAPI-RuiJ PET semi-quantitative parameters and clinicopathological characteristics in solid tumors
Correlation analysis between FAPI-RuiJ PET semi-quantitative uptake parameters (including SUVmax, SUVmean, SUVpeak, TBR and clinicopathological characteristics, including tumor markers (e.g., CEA, CA19-9, AFP, etc.), pathological subtype, and immunohistochemical markers (e.g., Ki-67, PD-L1, EGFR, etc.). Correlations will be assessed using Spearman's rank correlation coefficient (ρ), with statistical significance set at p \< 0.05.
Time frame
Through study completion, an average of 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov